Supply of immunoglobulin – Intravenous Immunoglobulin (IVIG) Kiovig

This article summarises the situation regarding the shortage of supply of intravenous immunoglobulin (IVIG) products as of April 2018. It also describes what is being done to minimise the impact to patients.

Intravenous Immunoglobulin (Kiovig)

Shire Pharmaceuticals who produce the IVIG preparation Kiovig have informed the NHS that there are supply issues with this product. They have advised the NHS that they are unable to fully meet the supply demands for the UK.

Shire has also taken the decision to withdraw from the commissioning framework for providing IVIG products from the 30th June 2018.  Furthermore their subcutaneous product Subcuvia will no longer be available from August 2018 and will be replaced by Cuvitru.

In England, Shire’s decision has aggravated an already fragile system of IG provision to PID patients following the decisions made by NHS England regarding routine commissioning of IG products – a situation which we highlighted in November 2017.

What actions have Shire put in place?

Shire has provided PID UK with a statement to explain their position and is working with the NHS to enable patients’ switching to alternative products.  Shire is also offering the NHS nursing support to help with the transfer of patients to their subcutaneous products where appropriate.

What is being done on a national level?

Everyone is working to help minimise the impact of the situation on the care of patients. The Commercial Medicines Unit (CMU) covering England and Northern Ireland, the National Plasma Products Expert Advisory Group (NPPEAG) in Scotland and the All Wales Immunoglobulin Strategy Group have been working with suppliers to secure alternatives to Kiovig.  Some alternative product options have been obtained from other companies; however overall there is a need to manage the limited volume of IVIG available. 

What this means for primary immunodeficiency (PID) patients

Patients on Subcuvia or Kiovig at present will need to switch to another available product.  New patients will be started immediately on the alternative products available to centres.  Your consultant and nursing teams will discuss with you the options on offer. 

Due to the IVIG shortage, and where appropriate, some patients on IVIG will need to be switched onto a subcutaneous immunoglobulin (SCIG) product and trained on how to have IG therapy using the subcut method of delivery.

This change will no doubt be a shock and create anxiety for those affected but your consultants and nursing teams will be on hand to talk over any of your concerns and to provide reassurance.  Many people with PID (60%) in the UK are already on SCIG and most patients switching from IVIG to this method of delivery actually begin to prefer it.

There will be a minority of patients for whom SCIG is not an appropriate option.  In this situation your immunology team will ensure you are able to continue to receive an IVIG product.

What this means for people with secondary antibody deficiency

Patients with secondary antibody deficiency who are currently on immunoglobulin will need to be switched as described for PID patients.

New patients diagnosed with secondary antibody deficiency will be trialled on antibiotic prophylaxis before starting on IG therapy and this has been the policy in the UK for many years.  If this trial fails, then IG replacement will be discussed on a per-patient basis again with SCIG being preferred over IVIG, but as per PID patients both remain an option.

Is the supply of IG secure for PID patients?

IG therapy is being used to treat an increasing number of different medical conditions that do not come under the PID umbrella. This is adding to the strain on the supply of IG in a lucrative and competitive, global market.  However, the NHS has systems in place to help safeguard IG supplies for PID patients.  The Department of Health runs a scheme to make sure that if a shortage develops, IG is reserved for patients who really need it, particularly people with immune deficiency.  These include clinical guidelines for IG use and the National Demand Management Programme for Immunoglobulin. You can find out more here.

Should I be concerned?

The situation is far from ideal and this news, and the changes it brings, place an extra burden on patients and family carers who are already dealing with the impact of coping with a long-term chronic illness.  However, you should be assured that there is sufficient IG therapy available to all PID patients in the UK.  Your immunology teams will be able to support you through the switching process.

What help can PID UK provide?

PID UK has produced a leaflet to help answer some of the questions patients, parents and carers may have about switching IG products.  

The PID UK website has a section dedicated to information about IG therapy.

There are three active facebook groups available for patients, carers and adolescents that can offer mutual support from patients to patients.  These are run by one of our patient representatives.

https://www.facebook.com/groups/ukpidpatients/
https://www.facebook.com/groups/ukpidcarers/
https://www.facebook.com/groups/ukpidadolescents/

You can also contact PID UK at hello@piduk.org with any concerns you may have.

Posted 19th April 2018